Annual Inspection; Electrical Safety Test; Basic Function Test - Surgiquest AirSeal i.F.S. Instructions D'utilisation

10

Annual Inspection

Each test conducted has to be documented with date and signature on the test
log.
The following measuring tools and resources were used by the manufacturer to
determine the listed measurements and tolerances:
Manometer Range 0-100 mmHg, error class 1.6
Syringe 60 ml
Silicone tube 8 x 2 mm
T adapter 8-8-8 mm
Veress needle length 100 mm
opening diameter 1.4 mm,
inner cannula diameter 1.6 mm
An authorized service technician must check the device if the specified parame-
ters and tolerances are exceeded.
10.1

Electrical Safety Test

1. Perform a visual inspection. Make sure that
• the fuse corresponds with the specifications indicated by the manufactur-
er,
• labels and stickers on device are legible,
• the mechanical condition of the device allows for its safe use,
• the device is clean to ensure proper and safe functionality.
2. Perform the measurement of the ground leakage current (max. 500 μA) and
contact current (max. 100 μA in normal state and max. 500 μA on first error)
according to IEC 60601-1 / EN 60601-1.
3. Measure protective conductor resistance according to IEC 60601-1 / EN
60601-1. The protective conductor resistance is measured while the device is
connected to the power supply. The max. value is 0.2 Ω.
As an alternative, perform safety test according to DIN EN 62353.
10.2

Basic Function Test

1. Conduct this test without the Single Lumen Filtered Tube Set connected to
the AirSeal® i.F.S.
2. Use the ON/OFF switch to turn the device on. The device now conducts a self-
test. A short acoustic signal can be heard. Press the Standard Insufflation
Mode key to select this operating mode.
3. The factory default settings are 15 mmHg for the nominal pressure and 5 l/
min for the nominal flow.
4. The following values are displayed:
Nominal pressure 15 mmHg
Nominal gas flow rate 5 l/min [button 1]
Actual pressure 0 mmHg
Gas consumption 0 l
5. Start insufflation:
Press the START key.
The following values are displayed: Actual pressure 0 mmHg
Initial insufflation is depicted.
Streaming gas can be heard at the insufflation tube connection.
Annual Inspection
Measured values and tolerances
EN
33